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Thromb Haemost 1997; 77(02): 262-266
DOI: 10.1055/s-0038-1655950
Original Article
Schattauer GmbH Stuttgart

Reliability of Five Rapid D-Dimer Assays Compared to ELISA in the Exclusion of Deep Venous Thrombosis

M C H Janssen
1   Department of Medicine, Division of General Internal Medicine, The Netherlands
,
A E Heebels
2   Department of Internal Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
,
M de Metz
3   Central Clinical Chemical Laboratory, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
,
H Verbruggen
4   Department of Medicine, Division of Central Hematological Laboratory, University Hospital, Nijmegen, The Netherlands
,
H Wollersheim
1   Department of Medicine, Division of General Internal Medicine, The Netherlands
,
S Janssen
2   Department of Internal Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
,
M M J Schuurmans
2   Department of Internal Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
,
I R O Nováková
5   Department of Medicine, Division of Hematology, University Hospital, Nijmegen, The Netherlands
› Author Affiliations
Further Information

Publication History

Received 02 August 1996

Accepted after revision 14 October 1996

Publication Date:
10 July 2018 (online)

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Summary

Studies measuring the fibrin degradation product D-Dimer (DD) using enzyme-linked immunosorbent assays (ELISA) in patients with venographically proven deep venous thrombosis (DVT) suggest that it is possible to exclude DVT when DD level is below a certain cut-off level. However, ELISA methods are time-consuming and not available in all laboratories. Different rapid latex-agglutination assays have been investigated, but their sensitivity is considerably lower.

In the present study we compared the value of four novel latex DD tests (Tinaquant®, Minutex®, Ortho® and SimpliRed®) and one rapid ELISA (VIDAS®) to a classical ELISA DD assay (Organon Mab Y18®) in 132 patients suspected of DVT.

The VIDAS®, a new quantitative automated ELISA, had a sensitivity of 100% and a negative predictive value of 100% for both proximal and distal DVT at a cut-off level of 500 ng/ml. The Tinaquant® assay, a new quantitative latex method, had a sensitivity of 99% and a negative predictive value of 93% for both proximal and distal DVT at a cut-off level of 500 ng/ml. For proximal DVT only, both assays had a sensitivity and negative predictive value of 100%. VIDAS® and Tinaquant® correlated well with ELISA (correlation of r = 0.96 and r = 0.98 respectively). Sensitivities of the semi-quantitative latex assays Minutex®, Ortho® and SimpliRed® were considerably lower (77%, 51 % and 61 % respectively).

These results suggest that VIDAS® and Tinaquant® may be used instead of ELISA DD in the exclusion of DVT. Tinaquant® can be performed within 20 min and VIDAS® within 35 min. Both assays might be used as a routine screening test and should be evaluated in large clinical management studies.

 

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